Mandibular occlusal inhibitor

ABSTRACT

A device for maintaining a patient&#39;s mouth in an open position during a medical procedure is provided. The device includes a cylindrical body configured to be received in the patient&#39;s mouth. A flange extending from an edge of the body is configured to engage the face of the patient, and preferably, the device includes a retainer for retaining the body in the patient&#39;s mouth.

PRIORITY CLAIM

[0001] This application is a continuation of co-pending U.S. applicationNo. 10/350,920, filed on Jan. 24, 2003, which is set to issue as U.S.Pat. No. 6,743,017 on Jun. 1, 2004, which claims priority to U.S.Provisional Patent Application No. 60/393,286, filed Jul. 2, 2002. Eachof the foregoing applications are hereby incorporated herein byreference.

FIELD OF THE INVENTION

[0002] The present invention relates to a device for holding a patient'smouth in an open position during medical, dental and surgicalprocedures.

DESCRIPTION OF THE RELATED ART

[0003] Medical professionals frequently perform procedures that requirethe patient's mouth to be held in an open position. For example, apatient's mouth must be held open during endoscopic procedures toprovide clearance for an endoscope and other instruments. A patient'smouth must also be held in an open or semi-open position when dentalbite-wing x-ray images are taken. A similar need exists in traumaevaluation and diagnosis of spinal injuries.

[0004] Spinal injuries require prompt evaluation by emergency healthcare providers. Early recognition of possible cervical spine injury(CSI) is of critical importance. Spinal injury may be difficult todiagnose in patients who are uncooperative, have altered mental status,or other distracting injuries. In such cases, it is difficult to obtainradiographic imagery to make a proper evaluation of the patient. Duringthe initial assessment, great care must be taken to adequately stabilizethe patient's spine and undertake cervical spine radiography for optimalpatient evaluation. Obtaining proper cervical spine films, particularlythe open-mouth odontoid view (OMV), in the pediatric and adultpopulations can be a challenging experience even under the best patientcircumstances. Patient-related concerns include inability to cooperateduring the procedure, repeat films, excessive radiation exposure, anddelays in care.

[0005] Data from the National Spinal Cord Injury Statistics Center(NSCISC) reports that approximately 10,000 new cases of cervical spineinjury (CSI) occur annually, with 1,100 of these cases occurring inchildren. Boys sustain injury more often than do girls and the mostcommon type of CSI is a combined fracture and dislocation injury. Theprimary mechanism by which children sustain this serious injury involvesblunt trauma from motor vehicle crashes, falls and sports-relatedaccidents. Children with congenital anomalies such as Trisomy 21,Klippel-Feil syndrome, mucopolysaccharidosis are at a greater risk forCSI due to bony abnormalities of the spine and laxity of the neck andspine ligaments.

[0006] Although CSI in children is rare, it generally carries a greaterdegree of morbidity and mortality in the younger pediatric populationwith associated head trauma. Spinal trauma in the young child oftenoccurs in the higher cervical spine area (C1-C3) due to the child'slarger head-to-body ratio and laxity of their ligaments. As thepediatric spine matures, it approaches adult-like configuration byaround eight years of age, as described in Herman, M. et al., CervicalSpine Disorders in Children, Orthop. Clin. Nor. Amer. 1999, 30(3):457-465. Although the adult spine can distribute traumatic forces moreevenly throughout the cervical vertebrae, they generally have a higherincidence of CSI than children, and sustain primarily lower C-spineinjury below the C3 level, as described in Manary, M. et al., CervicalSpine Injuries in Children, Ped. Ann. 1996, 25(8): 423-428.

[0007] It is estimated that 10-25% of patients with CSI suffer extensionof their injuries (paralysis or death) from delays in diagnosis, orunwarranted manipulation in the emergency department (ED) setting.Failure to adequately diagnose CSI promptly can lead to severeneurologic disability and morbidity. Two of the more common errors arefailure to obtain adequate C-spine roentgenograms and difficulty inx-ray interpretation.

[0008] According to the American College of Radiology AppropriatenessCriteria and the American College of Surgeons, the “golden standard” fortrauma evaluation of the cervical spine area is the three-view x-raythat includes the lateral, the anteroposterior (AP), and the OMV. SeeAmerican College of Radiology, ACR Appropriateness, Criteria forCervical Spine Trauma, 1995: 243-246; American College of Surgeons,Advanced Trauma Life Support (ATLS) Manual, 1997: 217-229. Propercervical spine x-rays for the evaluation of neck pain and neck injury inboth children and adults are critical. However, obtaining the OMV x-rayscan be technically difficult and time consuming for both the patient andthe emergency health care provider. See Buhs, C. et al., The PediatricTrauma C-spine: Is the Odontoid View Necessary? J. Ped. Surg. 2000,35(6): 994-997; Bonadio, W., Cervical Spine Trauma in Children: Part 1.General Concepts, Normal Anatomy, Radiographic Evaluation, Am. J. Emerg.Med. 1993, 11(2): 158-165; Schwartz, D. Introduction to Radiology, “In:Emergency Radiology”, New York: McGraw-Hill, 2000, 1-7, 291; Swischuk,L. et al., Is the Open-Mouth View Necessary in Children Under 5 Years?,Ped. Rad. 2000, 30:186-189. Depending on the patient's condition, it maybe very difficult to have the patient open their mouth and keep themouth open while radiography is performed. Problems may be attributed tothe patient's age, the patient's mental impairment, unconsciousness,pain or injury that distracts the patient, inability to open thepatient's mouth, and difficulties in positioning the patient.

[0009] Accordingly, it is desirable to provide a comfortable oral devicethat may used in a variety of applications, including radiography, tosecurely hold a patient's mouth in an open position.

SUMMARY OF THE INVENTION

[0010] In light of the foregoing, the present invention relates to adevice for maintaining a patient's mouth in an open position during adiagnostic, surgical or other medical procedure. The invention may beused in various applications, including but not limited to, radiology,endoscopy, dental treatment and surgical procedures. In radiology, forexample, the invention can be used to facilitate OMV x-rays for spinaltrauma evaluation. One or more components of the device are formed ofradiolucent materials. In this way, the device may be used inapplications such as radiography without visually obstructing x-rayimages.

[0011] One or more inner flanges may be provided on the device thatextend into the mouth. The inner flange or flanges may engage theinterior of the mouth and teeth to hold the mouth in an open position.Grooved or serrated surfaces may be provided on the inner flanges sothat the inner flanges are less prone to sliding or slipping as theycontact the patient's teeth. The device may also have one or more outerflanges. In one embodiment of the invention, the outer flange or flangesform loop handles that assist in placing the device in a patient'smouth. In another embodiment of the invention, the outer flange orflanges include rests or tabs that support the patient's lips while thedevice is inserted in the patient's mouth.

[0012] One or more wings may extend from the device to help keep thedevice in the patient's mouth. In one embodiment of the invention, thewings have solid faces and contain an adhesive pad. The adhesive padadheres to skin around the patient's mouth when the device is insertedin the patient's mouth to keep the device in place. In anotherembodiment of the invention, the wings have hollow apertures. Adhesivetape may be wrapped through the apertures and applied to the skin aroundthe patient's mouth to keep the inserted device in place. Alternatively,a flexible strap may be inserted through the apertures and pulled overthe patient's head to assist in holding the inserted device in place.The invention will be more fully described by reference to the followingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013]FIG. 1 is a perspective view of a mouth positioning device havingridged inner flanges in accordance with the present invention.

[0014]FIG. 2 is a fragmented front elevation view of the device of FIG.1.

[0015]FIG. 3 is a perspective view of an alternate embodiment of thepresent invention having inner flanges with occlusal recesses.

[0016]FIG. 4 is a perspective view of an alternate embodiment of thepresent invention having a pair of loop handles.

[0017]FIG. 5 is a perspective view of the device of FIG. 1 having anelastic strap for securing the device to a patient.

[0018]FIG. 6 is a perspective view of an alternate embodiment of thepresent invention having a pair of rests for supporting the patient'slips while the device is inserted in the patient's mouth.

[0019]FIG. 7 is a front elevation view of an alternate embodiment of thepresent invention having adhesive pads for securing the device to apatient.

[0020]FIG. 8 is a rear elevation view of the device of FIG. 7.

[0021]FIG. 9 is a front elevation view of the device of FIG. 4 insertedin the mouth of a patient.

[0022]FIG. 10 is a perspective view of an alternate embodiment of thepresent invention having a solid disk.

[0023]FIG. 11 is a front elevation view of the device of FIG. 10.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0024] Referring now to FIGS. 1-11 generally, and FIG. 1 in particular,a mouth positioning device in accordance with the present invention isshown and designated generally by reference number 10. Whereverpossible, the same reference numbers will be used throughout thedrawings and the description to refer to the same or like parts.

[0025]FIG. 1 is a perspective view of the mouth positioning device 10.The device 10 is configured to support and maintain a patient's mouth inan open position to permit completion of various medical, dental andsurgical procedures. The device 10 may be used in a number ofapplications, including but not limited to, radiology, endoscopy,dentistry and surgery. In radiology, the device 10 can be used inemergency trauma rooms or in free-standing radiology suites.

[0026] Referring now to FIGS. 1-2, the device 10 comprises a bodyportion 12. The body portion is formed of one or more radiolucentmaterials that permit passage of radiation or x-rays. In this way,radiographic images can be obtained with the device in place, withminimal obstruction or visible interference from the device. A varietyof radiolucent materials may be used, including but not limited tocomposites and thermoplastics.

[0027] The body portion 12 is formed of a soft, light-weight radiolucentmaterial, such as a soft polymer, composite or thermoplastic. Asmentioned above, plastics are radiolucent, which permits them to be usedin radiography. Soft plastics also provide sufficient rigidity tosupport a patient's jaw while offering some flexibility to reduce thestresses that may be exerted on the patient's mouth. Lighter-weightplastic materials also reduce the potential for tooth chipping or damagethat could occur when the device 10 is inserted quickly, such as in anemergency procedure. Preferably, the device 10 is formed of aninexpensive and disposable material, such as polyethylene.

[0028] In FIG. 1, the body portion 12 comprises a pair ofcrescent-shaped wings 14 connected by a loop handle 16. The wings 14form a rounded orifice or passage 17 through which instruments may beinserted during medical procedures. A pair of inner flanges 20 extendfrom the wings 14 in a direction that is generally normal to theorientation of the wings. The inner flanges 20 face one another in agenerally symmetrical and oval-shaped configuration that surrounds thepassage 17. As such, the inner flanges 20 are configured to be insertedinto the open mouth of a patient. The body portion 12 accommodates theinsertion of instruments having various sizes. The passage 17 mayprovide an opening up to 80 millimeters wide and accommodate a maximumFrench size greater than 60. Preferably, the passage 17 provides anopening that is at least 60 millimeters wide and accommodates a maximumFrench size of at least 60.

[0029] The inner flanges 20 are configured to contact a patient's teethin a stable and comfortable position after the device 10 is insertedinto the patient's mouth. The device 10 is structured so that thepatient's teeth engage or clamp down on the inner flanges 20.Preferably, the inner flanges 20 comprise surfaces that grip thepatient's teeth and minimize sliding or shifting of the device 10 in thepatient's mouth. Slide resistant surfaces may be formed in a number ofways. For example, the inner flanges 20 may be molded to provide acontoured or textured surface that frictionally engages the patient'steeth. In FIG. 1, the inner flanges 20 are shown with a series of ridgesor serrations 22 that provide resistance to sliding against thepatient's teeth. Alternatively, the inner flanges 20 may be contouredwith occlusal recesses 23 that conform generally to the patient's teeth,as shown in FIG. 3.

[0030] Referring again to FIGS. 1-2, the loop handle 16 provides amechanism for handling the device and guiding the device 10 into apatient's mouth. In this way, the medical professional avoids directhandling of the inner flanges 20 and other components that are insertedinto the patient's mouth. The loop handle 16 forms a rounded opening 18that permits insertion of one or more human fingers. The device 10 mayhave one loop handle 16, as shown in FIGS. 1-2. However, the presentinvention may also be provided with more than one loop handle. Referringto FIG. 4, an alternate device 110 is shown. The components of device110 that are similar to components of the device 10 are identified bythe same reference number plus 100. Device 110 has two loop handles 116that provide a mechanism for handling and guiding the device 110 into apatient's mouth.

[0031] For some patients, such as small children, the patient's mouthmay be smaller than the outer periphery of the inner flanges 20.Referring again to FIG. 2, the loop handle 16 provides a flexible bridgethat can be bent to permit insertion of the device 10 into the patient'smouth. The handle 16 is formed of a thin radiolucent material thatflexes to adjust the size of the device as it is inserted into apatient's mouth. More specifically, the handle 16 is formed of aresiliently flexible material, such as plastic, that bends to permit thewings 14 to be compressed or squeezed together. In this way, the wings14 and inner flanges 20 can be compressed inwardly as necessary so thatthe inner flanges fit into a patient's mouth opening. When compressiveforce is released from the wings 14, the resiliency of the loop handle16 creates a restoring force that restores the handle, wings and innerflanges 20 to their original positions. Preferably, the resiliency ofthe loop handle provides a relatively weak restoring force that can beovercome by the jaw strength of most patients. In this way, the loophandle 16 provides a snug fit in the patient's mouth without causing theinner flanges to bear harshly against the sides of the patient's mouth.

[0032] Referring again to FIG. 1, the device 10 is configured to beinserted into a patient's mouth so that the body portion 12 contacts thefacial area around the patient's mouth. The device 10 may be secured inthe patient's mouth to prevent the patient from spitting out or removingthe device during the performance of medical procedures. This may bedesirable in cases where the device is inserted in the mouth of atraumatized or uncooperative patient in need of prompt medicalevaluation. Referring to FIG. 2, the wings 14 comprise a pair ofapertures 15 that extend through the wings. The apertures 15 may be usedwith a variety of materials to hold and maintain the device 10 securelyin the patient's mouth. By providing the apertures 15, the amount ofmaterial required to make the body portion 12 is reduced, resulting in alighter-weight and lower cost product. In addition, the apertures 15 addflexibility to the device to improve patient comfort.

[0033] In FIG. 2, the device 10 is shown with strips of adhesive tape 30inserted through the apertures. The adhesive strips 30 are configured tocontact and adhere to skin around the patient's face when the device isinserted into the patient's mouth. In particular, each adhesive strip 30is inserted through an aperture 15 such that a side with adhesive isoriented toward the patient's face. As such, the device 10 can beinserted into a patient's mouth, and the adhesive tape 30 may applied tothe skin around the patient's mouth to hold the device in place.Referring to FIG. 9, the device 110 of FIG. 4 is shown secured to apatient's face with adhesive tape strips 130. The strips may contain anyadhesive compound suitable for contact with skin, such as adhesivecompounds used on bandages. The adhesive strips are preferably waterresistant to provide a bond that withstands moisture, such as patientperspiration or saliva.

[0034] The apertures 15 may also be used with a flexible strap 40 tohold the device 10 in place. Referring to FIG. 5, the device 10 is shownwith a large strap 40 having two ends inserted through apertures 15. Thestrap 40 is preferably an elastic strap that may be pulled around thepatient's head prior to inserting the device 10 in the patient's mouth.Preferably, the tension in the strap 40 is sufficient such that thestrap tightly engages the patient's head and securely holds the device10 in the patient's mouth. The strap 40 may be provided either as analternative to the adhesive strips 30, or in conjunction with theadhesive strips. In addition, the strap 40 may formed of a radiolucentmaterial, such as a thin plastic, for use in radiography.

[0035] As stated earlier, the device 10 is configured to be insertedinto a patient's mouth so that the body portion 12 contacts the facialarea around the patient's mouth. Preferably, the body portion 12 has oneor more lip rests 13, as shown in FIG. 6. The lip rests 13 areconfigured to spread and hold the patient's lips apart while the device10 is inserted in the patient's mouth. The lip rests 13 curve inwardlytoward the central passage 17 and provide a smooth surface that supportsthe patient's lips in a comfortable position.

[0036] In the preferred embodiment, the device 10 may be produced with aflavor element to be tasted by the patient when the device is insertedin the patient's mouth. The flavoring element may be one a variety ofcompositions or flavors, such as mint or citrus for example. Theflavoring is applied to the inner flanges 20, which extend into thepatient's mouth when the device is in use. The flavor element may bedeposited on the device using a variety of substances or processes. Forexample, the flavor element may be deposited with a spray, grease orcoating applied on the device 10. Moreover, the flavor element may bemixed into the material that forms the device to encapsulate theflavoring element to thereby preserve the flavor element.

[0037] Referring now to FIGS. 7-8, an alternate embodiment in accordancewith the present invention is shown and designated generally byreference number 210. Components that are similar to components of thedevice 10 are identified by the same reference number plus 200. Thedevice 210 comprises a body portion 212 and a pair of solid wings 214that extend outwardly from the body portion, similar to the previousembodiment. The solid wings 214 each comprise an adhesive pad 230configured to hold the device in place. In particular, each adhesive pad230 has a front adhesive face 232 that may be applied to the skin aroundthe patient's mouth to hold the device 210 in place. Each adhesive pad230 also has a rear face that is attached to a wing 214. The rear facesof the adhesive pads 230 may be attached to the wings 214 by bonding orany suitable connection. The adhesive faces 232 may contain any adhesivecompound suitable for contact with skin, such as adhesive compounds usedon bandages. The adhesive compound is preferably water resistant toprovide a bond that withstands moisture, such as patient perspiration orsaliva. The front adhesive faces 232 of the adhesive pads 230 may beprotected by covers 234 prior to use, as shown in FIG. 8. The covers 234are configured to be peeled back from the adhesive pads 230, asillustrated by the partially folded corners and arrows marked “A”. Thecovers 234 may be removed to expose the adhesive face immediately priorto inserting the device 210 in the patient's mouth. In this way, theadhesive compound does not dry or come in contact with other materialsprior to being applied to the patient's face.

[0038] Referring now to FIGS. 10-11, another embodiment of the presentinvention is shown and designated generally by the reference number 310.Components that are similar to components of the device 10 areidentified by the same reference number plus 300. The device 310comprises a body portion 312 formed of a radiolucent material, similarto previous embodiments. Instead of inner flanges, the body portion 312comprises a solid plate or disk 320 configured to contact a patient'steeth after the device 310 is inserted into the patient's mouth. Thedisk 320 may be molded to provide a contoured or textured surface thatfrictionally engages a patient's teeth. In FIG. 10, the disk 320 isshown with a series of ridges or serrations 322 that provide resistanceto sliding against a patient's teeth. The disk 320 may be desirablewhere a more rigid mouth support is required, or where the proceduredoes not require insertion of equipment through the inserted device 310.

[0039] It is to be understood that the above-described embodiments areillustrative of only a few of the many possible specific embodimentswhich can represent applications of the principles of the invention.Numerous and varied other arrangements can be readily devised inaccordance with these principles by those skilled in the art withoutdeparting from the spirit and scope of the invention as set forth in theclaims.

1. A mouth positioning device, comprising: a generally cylindrical bodyconfigured to be received in a patient's mouth, the body having an outersurface comprising a plurality of surface irregularities to provide agripping portion to be engaged by the patient's teeth; a flangeextending outwardly from a top edge of the body configured to engage theface of the patient; and a retainer configured to retain the body in thepatient's mouth.
 2. The device of claim 1 wherein the retainer comprisesone of an adhesive strip and a loop of flexible material configured toform a strap extending around the patient's head.
 3. The device of claim1 wherein the body is formed of radiolucent material.
 4. The device ofclaim 1 wherein the surface irregularities comprise a plurality ofridges.
 5. The device of claim 1 wherein the body comprises an orificeextending through the thickness of the body to provide an aperture forinserting an item into the patient's mouth when the body is inserted inthe patient's mouth.
 6. The device of claim 1 wherein the body comprisesfirst and second halves wherein a gap separates the first half from thesecond half.
 7. The device of claim 6 comprising a resilient armconnecting the first half with the second half such that the two halvescan be displaced relative to one another.
 8. The device of claim 1wherein the body is resiliently deformable such that the body can beflexed inwardly when being inserted into the mouth of the patient. 9.The device of claim 1 comprising a loop attached to the body andsubstantially co-planar with the flange.
 10. A mouth positioning device,comprising: a generally cylindrical body configured to be received in apatient's mouth wherein the body is formed of a radiolucent material; apair of wings extending outwardly from a top edge of the body configuredto engage the face of the patient; and a retainer configured to retainthe body in the patient's mouth.
 11. The device of claim 10 wherein theretainer comprises one of an adhesive strip and a loop of flexiblematerial configured to form a strap extending around the patient's head.12. The device of claim 10 wherein the body comprises an outer surfacehaving surface irregularities configured to be engaged by teeth of thepatient.
 13. The device of claim 12 wherein the surface irregularitiescomprise a plurality of ridges.
 14. The device of claim 10 wherein thebody comprises an orifice extending through the thickness of the body toprovide an aperture for inserting an item into the patient's mouth whenthe body is inserted in the patient's mouth.
 15. The device of claim 10wherein the body comprises first and second halves wherein a gapseparates the first half from the second half.
 16. The device of claim15 comprising a resilient arm connecting the first half with the secondhalf such that the two halves can be displaced relative to one another.17. The device of claim 10 wherein the body is resiliently deformablesuch that the body can be flexed inwardly when being inserted into themouth of the patient.
 18. The device of claim 1 comprising a loopattached to the body and substantially co-planar with the flange. 19.The device of claim 18 comprising a second loop attached to the body andsubstantially co-planar with the flange.
 20. The device of claim 10wherein the body has a thickness that is greater than the thickness ofthe wings.